Novel miRNA Assay Launched for Assessment of Pancreatic Masses

Asuragen, Inc. has announced the immediate availability of its miRInform^® Pancreas Test in its CAP-accredited CLIA Laboratory. The test was developed to aid physicians in the diagnosis and management of pancreatic ductal adenocarcinoma (PDAC) when cytology is inconclusive.

miRInform Pancreas is performed on fine needle aspirate (FNA) biopsies of solid lesions of PDAC patients. miRInform Pancreas analyzes the expression levels of small, regulatory FNA molecules known as microRNA’s (miRNA). An algorithm calculates a score between 0 and 1 by measuring the expression levels of seven miRNAs, and this determines whether or not PDAC has been identified.

The test was developed and validated in a large multicenter collaboration involving seven sites and 186 patients in accordance with CLIA and CAP regulations. The study showed that the miRInform^® Pancreas Test was able to accurately resolve over 75% of the FNAs that were indeterminate by cytology which comprised approximately 13% of the samples in the study. In addition, miRInform^® identified more than half of the PDAC samples within the 30% false negative samples resulting from cytology alone.

“The development and commercialization of miRInform^® Pancreas for FNA specimens represents another breakthrough for Asuragen and capitalizes on our deep molecular expertise and unsurpassed foundation in using miRNAs for diagnostic and therapeutic applications,” commented Matt Winkler, Ph.D., CEO. “We believe miRNAs will prove to be highly relevant for many additional cancer diagnostic applications.”